When you are auditing you will often find non-conformities. These occur when the department, process or organisation that you are auditing is not following a requirement of the standard that you are auditing against. For many of you who perform audits in the pharmaceutical industry – the standard that you will audit against is GMP. It is important that any non-conformities are linked with the standard that you are auditing against, so non-conformities against GMP must be linked to the relevant clause of GMP.

The following may be useful to you. It lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause – but additional clauses may exist. You should also refer to GMP itself to understand fully the context of each clause.

There is no mention in GMP of pen colour, the use of ditto marks, post-it notes or having a specific time and date format. However, if an organisation has a policy or procedure on such things – then they must follow their own system. Otherwise this is a non-conformity against 4.1 and 5.2.

8 Comments

You definitely hit on some of the popular findings I see all the time during cGMP audits! I always find it amazing how much we can read between the lines of the regulations. Take for example the US GMP regulation on equipment design which basically states that “equipment shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use.” That simple statement has ballooned into complex equipment validation, detailed change control, and intricate maintenance programs.

There’s a nice newsletter out there called GMP Trends which gives a nice monthly summary of FDA 483 observations.

Sometimes training records are found to be a mere paper work. During an vendor audit, I found a chemist trained in a particular analysis. When I was asking for how the calculation is arrived at, the concerned p[erson could not reply. Also, for out of specification, different versions are noticed. No common version could be found out. This is because of the complexity of the expressions/terminologies used in making the out of specifications.

I like this article and agree with other commentator regarding business based citations provided sense prevails and the auditor doesnt get too attached to the number he/she generates! These might best be recorded as “Comments”- this is what I have seen done before.

I agree to the above comments. I need to quote one example I came across. The company cleared a regulatory audit a week before. When a QA personnel from some other factory audited the firm for vendor approval, he could generagte around 20 NCs. Ofcourse, 5 of them were major and rest were minor. The firm attributed top the lineant view taken by its employees that they had cleared an international audit. So, people work only for audits. If the system is followed regularly, then there will not be any non-compliant. My boss used to say that we ahve to work as if everyday is an audit day.